Gene Integration Stability Test Service for Recombinant Strains

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Creative Biolabs offers industry-leading gene integration stability test for recombinant strains, a critical service for ensuring the stability and integrity of genetic elements integrated into host genomes. Recombinant strains play a pivotal role in biological production, and verifying their stability across generations ensures consistent product quality. Our extensive experience in method development and validation allows us to offer rapid and accurate stability tests, helping researchers and developers maintain the highest standards throughout the production lifecycle.

Choose Our Gene Integration Stability Test Services

Our gene integration stability testing services for recombinant strains begin with the isolation of enough clones to adequately sample the population of cells in the culture. This ensures comprehensive evaluation and provides a representative assessment of genetic stability. Creative Biolabs offers a series of molecular and microbial assays that can be applied to analyze the integration site of an expression construct. Additionally, our experts provide guidance on selecting the most appropriate approach for each specific recombinant strain product. Below is an overview of our core services:

Service	Description
Sequencing Analysis of the Transgene	Verifies the complete sequence integrity of the inserted gene.
Structure Analysis by Southern Blot	Confirms the correct insertion and structural integrity of the gene.
Transcript Analysis by RT-PCR and Northern Blot	Evaluates gene expression at the RNA level to ensure stable transcription.
Identity Testing for Recombinant Strains	Ensures the authenticity and integrity of recombinant strains.
Gene Insertion and Copy Number Assessment by qPCR	Determines the transgene copy number and verifies gene stability.

Our suite of assays ensures precise and reliable evaluation of the genetic stability of recombinant strains, helping maintain product quality and compliance with regulatory standards. In addition to these standardized services, Creative Biolabs offers customized testing solutions to address the unique requirements of each project, inquiry now.

Platform and Technology Support

At Creative Biolabs, cutting-edge platforms enable us to deliver precise gene integration stability testing. Key technologies include:

Next Generation Sequencing (NGS): Recognized as a powerful tool for detecting even subtle genetic changes. NGS enables comprehensive analysis through full genome sequencing, helping avoid repetitive assays.
Target Enrichment Sequencing: Facilitates the mapping of integration sites with high specificity by targeting specific genome regions.
LAM-PCR and nrLAM-PCR: Advanced PCR-based methods to identify and validate integration sites.
Whole Genome Sequencing (WGS): Suitable for characterizing production strains like CHO cells and microbial hosts.

These advanced tools allow us to meet regulatory guidelines while delivering reliable data to guide biotherapeutic development.

Service Advantages

Creative Biolabs provides several advantages in delivering Gene Integration Stability Test for Recombinant Strains:

Validated Assays with High Accuracy: All our assays meet stringent industry standards, ensuring the most reliable results.
Fast Turnaround Time: Our streamlined workflows enable us to provide quick results without compromising quality.
Cost-Efficiency: Tailored service designs allow us to optimize processes, reducing project costs for clients.
Comprehensive Support: Our expert team offers end-to-end collaboration, ensuring smooth project execution.
Advanced Technology Platforms: By leveraging the latest sequencing technologies, we deliver precision testing that meets both regulatory and research needs.

Background of Gene Integration Stability in Recombinant Strains

Recombinant strains are engineered to contain therapeutic genes or biologically active sequences. However, random integration of transgenes into host genomes can result in genomic instability over time, posing risks to product consistency and safety. During strain cultivation, deletions, point mutations, or rearrangements may occur, affecting gene expression and the phenotype of the strain.

Gene integration stability testing addresses these risks by verifying the homogeneity of the recombinant genome and identifying any unintended genomic events. Regulatory frameworks, including the ICH Q5B, require stability testing to confirm that recombinant systems maintain their genetic sequence from the Master Cell Bank to End of Production cells.

PCR samples ready for a thermal cycler (Creative Biolabs Authorized)

Applications of Gene Integration Stability Testing for Recombinant Strains

Gene integration stability tests are essential across multiple applications. Here are some of the key areas:

Application	Description
CHO Cell Line Development	Stability testing ensures consistent protein production in biopharmaceuticals.
Autologous CAR-T Cells	Verifies the stability of therapeutic gene insertions in CAR-T cell therapy production.
Plasmid Vaccine Manufacturing	Monitors transgene integrity in plasmid-based vaccines.
Microbial Fermentation Systems	Ensures the stability of microbial production strains used for biological synthesis.

Other Related Services

Creative Biolabs offers a variety of complementary services that support biological development and enhance recombinant strain production. Below are some related offerings:

Microbial Isolation and Screening

Biological Safety Test

Microbial Fermentation

QC Analytical Testing

These services work in tandem with gene integration stability tests, ensuring comprehensive solutions for biological production systems. Please contact us to find out what Creative Biolabs can do for you.